Name: Dersimelagon (MT-7117) in Erythropoietic protoporphyria or X-linked protoporphyria: Phase of product development
Published: 2026-09-21T21:42:40-04:00

FDA acceptance of the New Drug Application with Priority Review

“The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for dersimelagon for filing and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) date expected by the end of February 2027.” (opens the source at this quote in a new tab)
“LEO Pharma, a global leader in medical dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the New Drug Application (NDA) for dersimelagon, a potential first-in-class oral therapy for EPP and XLP. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date by the end of February 2027.” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted June 2026

“On June 30, 2026, Tanabe Pharma America submitted a New Drug Application (NDA) to the FDA for dersimelagon for the treatment of EPP and XLP. Tanabe Pharma will continue its efforts toward obtaining approval in the U.S.” (opens the source at this quote in a new tab)

“Tanabe Pharma has initiated preparations for a New Drug Application (NDA) rolling submission.” (opens the source at this quote in a new tab)

Launch: Potential launch in 2027

“The acquisition is expected to increase LEO Pharma’s investments in 2026 for pre-launch activities and in 2027 for a potential launch.” (opens the source at this quote in a new tab)

Sponsor statement of the review acceptance and decision timing

“the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an investigational oral selective melanocortin 1 receptor (MC1R) agonist, MT-7117 (dersimelagon), for the treatment of erythropoietic protoporphyria (EPP) and X-Linked Protoporphyria (XLP).” (opens the source at this quote in a new tab)
“The FDA has granted Priority Review, with a decision expected by the end of February 2027.” (opens the source at this quote in a new tab)

Fast Track and Orphan Drug designations

“Dersimelagon received Fast Track Designation from the U.S. FDA in June 2018 and was granted Orphan Drug Designation in June 2020.” (opens the source at this quote in a new tab)

“Dersimelagon has been granted both U.S. FDA Fast Track Designation and Orphan Drug Designation, and an NDA for the treatment of EPP and XLP was submitted to the U.S. FDA for regulatory review in June 2026, but has not yet been approved by the FDA or any other regulatory agency.” (opens the source at this quote in a new tab)

“Tanabe Pharma received Fast Track Designation for dersimelagon by the U.S. Food and Drug Administration in June 2018.” (opens the source at this quote in a new tab)

European Union orphan designation

“This medicine was designated as an orphan medicine for the treatment of erythropoietic protoporphyria in the European Union on 16 March 2022.” (opens the source at this quote in a new tab)

Designation field	Quoted record
Active substance	“dersimelagon”
Intended use	“Treatment of erythropoietic protoporphyria”
Orphan designation status	“Positive”
EU designation number	“EU/3/22/2585”
Date of designation	“16/03/2022”
Sponsor	“Tanabe Pharma GmbH”

European Union submission route and expected registration

Horizon-scan field	Quoted record
Registration route	“Centralised (EMA)”
Submission date	“July 2026”
Expected Registration	“August 2027”
Orphan drug	“Yes”

Approval status

“If approved, dersimelagon could become the first oral treatment for EPP and XLP, helping to address a significant unmet medical need. Dersimelagon has not yet been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established by any regulatory authority.” (opens the source at this quote in a new tab)

Development activity in China

“A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Single and Multiple Doses of MT-7117 in Chinese Healthy Subjects” (opens the source at this quote in a new tab)

Regulatory submission in Japan

No evidence found.